Understanding of Psychotic Disorders in Children With 22q11.2DS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: neuropsychological testing, questionnaires and experimental tasks.
- Who it may be relevant to
- Registry conditions: 22q11.2 Deletion Syndrome. Basic parameters: 4 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Characterize the Behavioral Prodromes of Psychotic Disorders in Children With 22q11.2DS Aged From 4 to 13 Years Old
Overview
The study PremiCeS22 will investigate the prodromal signals at the onset of psychotic disorders of children with 22q11.2 deletion syndrome
Detailed description
22q11.2DS is one of the most common microdeletion syndromes (1 / 2000-1 / 4000 births) and one of the most robust genetic risk factors for schizophrenia (1 to 2% of cases). Reciprocally, approximately 30% of patients with 22q11.2DS will develop psychotic symptoms in adolescence or early adulthood. It is now well established that children and adults with 22q11.2DS have lower social skills than developing youth. These social dysfunctions could be partly underpinned by alterations in social cognitive processes, and could also be linked to the emergence of psychotic signs or even schizophrenia. However, to our knowledge, no study has investigated the existence of behavioral prodromal signs during the onset of psychotic signs in children with 22q11.2DS. In addition, the origin of social cognitive processes remains to this day little explored.
Interventions
- Behavioral neuropsychological testing, questionnaires and experimental tasks
Neuropsychological testing (the Sky Search subtest from the Test of Everyday Attention for Children (TEA-Ch); the Overlapping lines task of Rey; auditory attention of NEPSY II battery); questionnaires completed by the children's legal representatives to assess behavior; experimental tasks evaluating gaze direction and facial expression recognition
Primary outcome measures
- The Screen for child Anxiety Related Emotional Disorders (SCARED) [Time frame: Day 1]
- facial expression recognition task [Time frame: Day 1]
Secondary outcome measures (4)
- Sustained hearing attention test (Tea-Ch battery) [Time frame: Day 1]
- Rey's Tangled Lines Test [Time frame: Day 1]
- NEPSY II battery [Time frame: Day 1]
- Mean reaction time [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- Diagnosis of 22q11.2 deletion syndrome or no developmental disease
- Aged from 4 to 13 years old
- French language
Exclusion criteria
- Diagnosis of intellectual deficiency according to DSM 5 criteria
- Drug prescribed for somatic condition that could influence cerebral functioning
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- Hopital Vinatier — Lyon
Identifiers
NCT: NCT04639388 · 2020-A01370-39